Core B - Clinical Core

PROJECT ABSTRACT – CORE B (CLINICAL CORE) The Washington University Cooperative Center on Human Immunology (WashU-CCHI) Clinical Core (Core B) combines the resources of two highly successful clinical research units at Washington University, the Infectious Disease Clinical Research Unit (IDCRU) led by Rachel Presti, MD, PhD, and the Emergency Care Research

Core (ECRC) led by Philip Mudd, MD, PhD, as well as a Statistical Unit led by Charles Goss, PhD. The combined units provide highly experienced faculty, clinical coordinators, statisticians, laboratory technicians, data and quality personnel, and pharmacy support with the expertise to conduct the proposed clinical studies of the

WashU-CCHI. The leads of the three units have a history of successful collaboration with both each other and the investigators leading the proposed CCHI scientific projects. We have designed our research approach in close collaboration with scientific leads of Projects 1 and 2 to design cutting edge clinical and translational

research projects that are able to obtain and curate samples and clinical information to address many key questions in the immunology of both infection and vaccination against influenza and SARS-CoV-2. We have established functional and collaborative relationships with other Departments and Divisions at Washington

University, including Emergency Medicine, Radiology, Hematology/Oncology, and Pulmonology, which have allowed us to collect unique samples, including lymph node fine needle aspirates (FNA) and core biopsies (CB), bone marrow aspirates (BMA), bronchoalveolar lavage (BAL) and endobronchial biopsies (EBBx), in addition to

blood, saliva, and nasal swabs collected in the research units. The IDCRU is well positioned to enroll participants in vaccine studies that include metabolic labeling with deuterium labeled water to determine the temporal origin and turnover rate of immune cells as well as biospecimen collection including FNA, CB, BMA, BAL and EBBx.

ECRC is well positioned to enroll participants with acute infection and collect BAL, EBBx as well as blood, saliva, and nasal swabs. Our processing laboratories have developed seamless protocols to perform initial processing and collaborate closely with research labs for more specialized processing of samples. Design and analysis of

the clinical protocol and research projects will be enabled by expert statisticians in the Statistical Unit.